Laparoscopic SurgeryEnSEMbLENCT04111679
EffectS of prEferred Music on Laparoscopic performancE
A study testing Music in people with Laparoscopic Surgery and Music, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The main objective is to investigate whether listening to recorded music has a positive effect on the execution of laparoscopic skills. Secondary objectives are to investigate the effects of music during surgical performance on blood pressure, mental workload and heart rate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Surgery, Music, Surgical Education
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study a subject must meet all of the following criteria.
- Age ≥ 18 years
- Medicine students
- Provision of written informed consent by the subject.
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Severe hearing impairment, defined as no verbal communication possible.
- Severe visual impairment, defined as not able to see the monitor on which the laparoscopic task is projected.
- Any physical handicap that impairs laparoscopic performance (unable to stand for 10 minutes, unable to hold and use both instruments.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preferred Music on Laparoscopic Performance
The main objective is to investigate whether listening to recorded music has a positive effect on the execution of laparoscopic skills.
Secondary objectives are to investigate the effects of music during surgical performance on blood pressure, mental workload and heart rate.
Read more
Study design: This will be a 4-period 4-sequence 2-treatment crossover study, participants will be exposed to both control (noise cancelling headphones without music) and the intervention (preferred music via headphones) whilst performing a laparoscopic task in a box trainer. Every period consists of 5 repetitions of a laparoscopic peg transfer task. In total participants will perform in each condition 10 peg transfer tasks.
Prior to the experiment, all participants practice the laparoscopic peg transfer task 20 times
Study population: Healthy volunteering medicine students without laparoscopic experience.
Intervention (if applicable): Participants will perform 2 periods of 5 laparoscopic peg transfer task whilst listening to preferred recorded music via headphones and 2 periods of 5 laparoscopic peg transfer tasks while wearing noise cancelling headphones without music (2 periods of 5 tasks).
Main study parameters/endpoints: The primary endpoint is laparoscopic performance as defined by time of task completion Secondary endpoints are: laparoscopic task performance (path length, jerk, error score, economy of motion) vital parameters (heart rate, and post test blood pressure) and mental workload (SURG-TLX)
- Conditions
- Laparoscopic Surgery, Music, Surgical Education
- Being tested
- Music
- Keywords
- Surgical skill, Music, Laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Participant selected music, applied using noise cancelling headphones
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | During laparoscopic task performance; participants will wear a noise cancelling headphone that plays music that is chosen by the participant. Receives: Other: Music |
| No music | No intervention | During laparoscopic task performance; participants will wear a noise cancelling headphone that does not play music. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to task completion (s)
It will be measured in seconds and calculated using data generated from motion analysis software. Each tasks starts, when the participants puts the tip of the grasper in a yellow square that is projected on the screen, after task completion the participant puts tip in the square again to finish the task. The time between start and finish is defined as the time to task completion.
An average is calculated for both the 10 tasks in the intervention group and the 10 tasks in the control group.
Measured: This will be measured during the experimental session which will take up about 1 hour in total
Secondary outcomes (6)
Path length
The total distance the tip of the instrument has travelled per task (mm) per task, it will be calculated using data generated from motion analysis software. Each tasks starts, when the participants puts the tip of the grasper in a yellow square that is projected on the screen, after task completion the participant puts tip in the square again to finish the task. An average is calculated for both the 10 tasks in the intervention group and the 10 tasks in the control group.
Measured: This will be measured during the experimental session which will take up about 1 hour in total
Normalized jerk
the rate of change of acceleration of the instrument tips (m/s3) per task. It will be calculated using data generated from motion analysis software. Each tasks starts, when the participants puts the tip of the grasper in a yellow square that is projected on the screen, after task completion the participant puts tip in the square again to finish the task. An average is calculated for both the 10 tasks in the intervention group and the 10 tasks in the control group.
Measured: This will be measured during the experimental session which will take up about 1 hour in total
Mental workload
Mental workload will be assessed using the Surgery task load index (SURG-TLX) this is a validated multidimensional, surgery-specific workload measure. The SURG-TLX is an adapted version of the National Aeronautics and Space Administration Task Load Index (NASA-TLX).
In the SURG-TLX subjects rate six dimensions of workload i.e. situational stress, distractions, task complexity, physical demands, temporal demands and mental demands on visual analogue scales VAS ranging from 0-100 (0 = very low;100 = very high) the scores of these subscales are combined into a weighed average that results in a general score ranging from 0-100 (0 = very low; 100 = very high) After every period of 5 tasks a SURG-TLX questionnaire is completed. An average is calculated for both the two periods in the intervention group and the two periods in the control group. The averages of both the general score and the individual subscales will be reported.
Measured: This will be measured during the experimental session which will take up about 1 hour in total
Heart rate
Heart rate will be assessed prior to; and immediately after every period of laparoscopic tasks in beats per minute. Change in heart rate before and after each period of tasks is calculated. An average change will be calculated for both the two periods in the intervention group and the two periods in the control group
Measured: This will be measured during the experimental session which will take up about 1 hour in total
Blood pressure
Systolic and diastolic pressure will be assessed prior to and immediately after every period of laparoscopic tasks in mmHg. Change in blood pressure before and after each period of tasks is calculated. An average change will be calculated for both the two periods in the intervention group and the two periods in the control group
Measured: This will be measured during the experimental session which will take up about 1 hour in total
Participant's characteristics
- Age (years)
- Sex (male or female)
- Dexterity (left- or right handed, ambidextrous)
- Year of medical education:
- The importance of music in daily life on a (10-point numeric rating scale)
- Musical genres the subject listens to (classical, world music, rock, pop, techno, house, jazz, blues, disco, other)
- Musical genres the subject listens to when studying: (classical, world music, rock, pop, techno, house, jazz, blues, disco, other)
- choice of music during the experiment
- Whether or not the subject plays or has played a musical instrument (never, in the past, currently)
- Whether or not the subject plays or has played video games and to what extends (never, in the past, currently)
This questionnaire will be completed before starting the practice session of 20 laparoscopic tasks.
Measured: This will be measured during the experimental session which will take up about 1 hour in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Jun 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a 4-period 4-sequence 2-treatment crossover study, participants will be exposed to both control group (A), the silent group, and intervention group (B), the music group, whilst performing a laparoscopic task in a box trainer. Participants will be randomly assigned to a sequence that determines in which order they are being exposed to both auditory environments
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. Gert-Jan Kleinrensink, Erasmus Medical Center
- Investigators
- Gert-Jan Kleinrensink, Prof. Dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111679
- Sponsor's protocol ID
- MEC-2018-1134
- Acronym
- EnSEMbLE
- Status last verified
- Nov 2019
- First submitted
- 4 Sep 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oomens P, Fu VX, Kleinrensink VEE, Kleinrensink GJ, Jeekel J. The Effects of Preferred Music on Laparoscopic Surgical Performance: A Randomized Crossover Study. World J Surg. 2020 Aug;44(8):2614-2619. doi: 10.1007/s00268-020-05523-0.
PubMed 32333159
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preferred Music on Laparoscopic Performance
- ClinicalTrials.gov ID
- NCT04111679
- Acronym / sponsor ID
- EnSEMbLE / MEC-2018-1134
- Conditions
- Laparoscopic Surgery, Music, Surgical Education
- Keywords
- Surgical skill, Music, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to investigate whether listening to recorded music has a positive effect on the execution of laparoscopic skills.
Secondary objectives are to investigate the effects of music during surgical performance on blood pressure, mental workload and heart rate.
Study design: This will be a 4-period 4-sequence 2-treatment crossover study, participants will be exposed to both control (noise cancelling headphones without music) and the intervention (preferred music via headphones) whilst performing a laparoscopic task in a box trainer. Every period consists of 5 repetitions of a laparoscopic peg transfer task. In total participants will perform in each condition 10 peg transfer tasks.
Prior to the experiment, all participants practice the laparoscopic peg transfer task 20 times
Study population: Healthy volunteering medicine students without laparoscopic experience.
Intervention (if applicable): Participants will perform 2 periods of 5 laparoscopic peg transfer task whilst listening to preferred recorded music via headphones and 2 periods of 5 laparoscopic peg transfer tasks while wearing noise cancelling headphones without music (2 periods of 5 tasks).
Main study parameters/endpoints: The primary endpoint is laparoscopic performance as defined by time of task completion Secondary endpoints are: laparoscopic task performance (path length, jerk, error score, economy of motion) vital parameters (heart rate, and post test blood pressure) and mental workload (SURG-TLX)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a 4-period 4-sequence 2-treatment crossover study, participants will be exposed to both control group (A), the silent group, and intervention group (B), the music group, whilst performing a laparoscopic task in a box trainer. Participants will be randomly assigned to a sequence that determines in which order they are being exposed to both auditory environments
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: MusicDuring laparoscopic task performance; participants will wear a noise cancelling headphone that plays music that is chosen by the participant. |
| No music | No intervention | –During laparoscopic task performance; participants will wear a noise cancelling headphone that does not play music. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- In order to be eligible to participate in this study a subject must meet all of the following criteria.
- Age ≥ 18 years
- Medicine students
- Provision of written informed consent by the subject.
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicParticipant selected music, applied using noise cancelling headphones | Other | Music |
Primary outcome
Time to task completion (s)
Time frame: This will be measured during the experimental session which will take up about 1 hour in total
It will be measured in seconds and calculated using data generated from motion analysis software. Each tasks starts, when the participants puts the tip of the grasper in a yellow square that is projected on the screen, after task completion the participant puts tip in the square again to finish the task. The time between start and finish is defined as the time to task completion. An average is calculated for both the 10 tasks in the intervention group and the 10 tasks in the control group.
6 secondary outcomes
Path length
Time frame: This will be measured during the experimental session which will take up about 1 hour in total
Normalized jerk
Time frame: This will be measured during the experimental session which will take up about 1 hour in total
Mental workload
Time frame: This will be measured during the experimental session which will take up about 1 hour in total
Heart rate
Time frame: This will be measured during the experimental session which will take up about 1 hour in total
Blood pressure
Time frame: This will be measured during the experimental session which will take up about 1 hour in total
Participant's characteristics
Time frame: This will be measured during the experimental session which will take up about 1 hour in total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Derived from this study: PubMed 32333159Oomens P, Fu VX, Kleinrensink VEE, Kleinrensink GJ, Jeekel J. The Effects of Preferred Music on Laparoscopic Surgical Performance: A Randomized Crossover Study. World J Surg. 2020 Aug;44(8):2614-2619. doi: 10.1007/s00268-020-05523-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gert-Jan Kleinrensink, Prof. Dr. principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Laparoscopic Surgery and Music, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to task completion (s) (time frame: This will be measured during the experimental session which will take up about 1 hour in total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04111679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.